Baxter Healthcare Corporation – FDA Warning Letter, Apr 19, 2013

This FDA Warning Letter (13-ATL-17) was issued to Baxter International Inc. following inspections of their Marion, North Carolina (November 7-16, 2012, and March 13-April 19, 2013) and Jayuya, Puerto Rico (March 13-April 19, 2013) pharmaceutical manufacturing facilities. The inspections identified significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated.

At the Marion, NC facility, violations included: 1. **Failure to clean and maintain equipment (21 CFR 211.67(a)):** HEPA filters and supporting structures on Fill Line (b)(4) contained discolored areas, chipping paint, and mold (TNTC). Baxter's response was inadequate as it did not identify the duration of the conditions or the root causes. This was a repeat observation. 2. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** Visible discoloration and "possible mold" on HEPA filters were documented since July 2010 but not properly investigated or remediated. Baxter's response was inadequate for not performing a risk assessment on all affected products manufactured since July 2010 and still on the market. This was a repeat